Your Money or My Life

I have a disease called idiopathic membranous glomerular nephritis. Try saying that three times fast. Then try paying $38,000 per teaspoon for the only drug that might keep me alive.

My disease results in a secondary condition called “nephrotic syndrome.” All this means that my immune system is mistakenly attacking my kidneys and causing them to mishandle protein. Instead of putting protein in my blood, where it belongs, they put it in my urine, where it doesn’t.

I’ve taken ten pages’ worth of tests — X-rays, MRIs, innumerable blood samplings — and still no one knows why my body started acting this befuddled way — hence the term “idiopathic,” meaning, “who the heck knows?”

One in three Americans is at risk for some kind of kidney disease. My primary symptom is edema — the buildup of fluid under the skin that causes me to bloat and gain weight. Without pee-inducing diuretics to help drain away the fluid, I end up looking blubbery all over — kind of like a Macy’s Thanksgiving Day parade balloon. In August of 2016 I went from 160 pounds to 182 pounds in ten days. That’s when I knew something was wrong. (I’m six feet tall and, usually, skinny.) I’m also tired a lot and have had to give up tennis and most of my long-form writing — I can’t handle the hours at the computer. I can still play golf, as long as I ride. I’m in no pain. I’m not asking for sympathy.

What I am asking is for someone to do something about the U.S. pharmaceutical industry and the price of drugs. Certain members of Big Pharma are engaged, it seems to me, in a form of medical extortion: “Pay us, or die.” You could also call it a protection racket. The amount of money these drug companies demand is obscene. In this case, I’m the victim.

If I don’t go into remission, my kidneys will stop functioning within 24 to 36 months. That means dialysis, transplant, or death. At this point, my best chance of going into remission is to take a drug called Acthar gel. That’s the advice from my Columbia University Medical Center doctor, who happens to be one of the world’s leading authorities on this disease. (As a Columbia alumnus, I had connections.)

Acthar gel is injected at home, do-it-yourself. It doesn’t hurt, but it’s still no fun injecting yourself, so I get my partner Gail to do it, twice a week, into a muscle in my thigh. If nothing else, this whole situation has reminded me once again that Gail is a saint.

Now about money: Every two and a half weeks, I get a delivery of Acthar gel from a specialized pharmacy called Accredo Health Group. The drug comes in 5-milliliter vials. Five milliliters is about a teaspoon. I get five injections per vial. Each vial, about the size of a thimble, costs $38,000. You read that right: a thimble of this medicine costs $38,000.

I will need at least five thimbles, maybe ten. That means my Acthar treatments will cost me (actually, you) $190,000 — more, if I need more treatments. Acthar is reported to be one of the five most expensive drugs in the world.

It was pretty funny when the UPS guy who delivered my first vial dropped the package it was in onto the front lawn. Fortunately, it was packaged as tens of thousands of dollars’ worth of magic juice ought to be packaged — in a beer-cooler-sized Styrofoam container — and the little insanely expensive vial was unharmed.

Acthar gel has been around for more than 60 years. It has long been used to treat infantile seizures and symptoms of multiple sclerosis. It’s made from the glands of pigs slaughtered in the meat houses of Middle America. Originally it was made by the Armour meat-packing company. Yes, my $38,000-per-teaspoon medicine was originally discovered and marketed by the folks most famous for making hotdogs.

Until the year 2001, Acthar gel, then still manufactured by Armour, cost only about $40 per thimble-sized vial. Then Armour sold the rights to the drug to a pharmaceutical giant called Questcor. By 2007 Questcor had raised the price to $23,000 per thimbleful. In 2013 the Federal Trade Commission (FTC) sued Questcor for buying the rights to a synthetic version of Acthar used in Europe and quashing the studies of the synthetic in the U.S. so it could continue to make huge profits from natural Acthar gel. The FTC fined Questcor $100 million.

In 2014, a Big Pharma company called Mallinckrodt, which is registered in Ireland and which has U.S. headquarters in St. Louis, bought Questcor and ended up with control of Acthar gel. Malinckrodt raised the price of Acthar gel to the current $38,000 per thimble-sized vial. Mallinckrodt paid off the $100 million fine Questcor owed for trying to quash the synthetic drug and promised to do testing on the effectiveness of the synthetic substitute. I don’t know if it has done that.

In recent years, researchers discovered, more or less by accident, that, in addition to helping with infantile seizures and multiple sclerosis, Acthar gel sometimes seems to bring about remission of nephrotic syndrome — my main kidney problem. My own doctor did part of that research, some of it supported by Mallinckrodt. I try not to think about any possible conflicts of interest; I trust my doctor, who makes it clear in his published articles that he has accepted no personal money directly from Mallickrodt for speeches, honorariums, salaries, or anything else. If I get better, I’ll be glad Mallinckrodt sponsored his research. As of this moment, the cheaper synthetic version of Acthar is not approved in the U.S. for use on nephrotic syndrome, but it is approved in Europe.

Mallinckrodt has a monopoly on Acthar gel. No one else can make it or sell it in the U.S. It is an “orphan drug,” meaning relatively few people take it — fewer than 10,000 or so. In order to motivate a company to make it, the government allows the patent-holder basically to charge whatever it wants; otherwise, given the few patients using it, the company supposedly wouldn’t make enough money to make it worth their while to produce it. Yet, despite the few patients using it, Mallinckrodt is now reported to earn about $1 billion per year from Acthar gel alone. That’s “billion.”

Mallinckrodt says that it has donated more than $774 million in Acthar at no cost to patients, but it’s still making $1 billion per year from this one drug. Mallinckrodt is not donating anything to me, and there’s no need for it to. I get my donations from you, the healthy American taxpayer. Here’s how that works.

Many of us who must take Acthar for nephrotic syndrome are on Medicare. I’m 71 years old, so I have Medicare and, lucky for me, Medicare Part D — the drug element of Medicare — which usually covers about 95 percent of one’s drug costs. Medicare is reported to pay out at least $500 million a year to cover the costs of Acthar gel for folks like me.

I suggest you read that previous sentence again: $500 million in taxpayer dollars — your dollars — is spent to cover a single drug used by relatively few people. I am, essentially, on pharmaceutical welfare. If you’re a healthy taxpayer, you’re paying my drug bills through Medicare and, probably, other insurance.

Before I agreed to take Acthar, I of course went online to find out how much it costs. I quickly grew pale: I couldn’t afford $38,000 per teaspoon. It was time to look into my insurance.

I’m a reasonably intelligent person. As a writer, I know how to do research. Nevertheless, I quickly got lost in the forest of insurance. As I said, I’m on plain Medicare, but that covers just doctors and operations (I think), not drugs. I also pay $350 per month for Anthem Blue Cross and Blue Shield insurance that supplements my Medicare coverage with eye and dental coverage and that includes Medicare Part D, which covers drug costs. I hoped Medicare Part D, a taxpayer-subsidized program, would cover most of my Acthar costs. It should have been simple to call someone to find out.

It was not simple at all.

I started with Mallinckrodt, the company that owns the rights to the drug. They said I should talk to the folks at Accredo Pharmacy, which, as I said, makes the drug for Mallinckrodt and delivers it to patients. At first, the folks at Accredo told me that because Acthar was a “specialty” drug, my Medicare Part D insurance would pay only 80 percent of its cost, leaving me to pay, they estimated, about $5,800 for each little vial of Acthar — about $29,000 total for the five vials I’d need. If it were not a specialty drug, I was told, Medicare Part D would cover 95 percent, not just 80 percent, of my Acthar costs. The folks at Accredo then suggested I call Express Scripts to double-check that information.

Express Scripts is an opaque company that handles drugs for Medicare. It also has some kind of business relationship with Accredo Pharmacy, the maker of my drug. Medicare won’t approve the use of a drug unless Express Scripts gives the okay. Those of us dealing with a long-term disease and expensive drugs live in fear that Express Scripts will not approve the drugs we need to use. They have a “formulary” that lists approved drugs. Acthar was not on Express Scripts’ published 2017 formulary, so I was worried that Medicare Part D wouldn’t cover my drug at all.

Fortunately, Express Scripts said that they would cover part of my Acthar costs. Like Accrredo, they also called it a “specialty” drug and said I’d have to pay 20 percent of my Acthar costs instead of just 5 percent (what I’d pay if it were not a specialty drug). I figured my out-of-pocket cost should then have been 20 percent of $190,000 (about $38,000) for five vials of Acthar gel, but for some reason I never understood, a supervisor at Express Scripts estimated my total out-of-pocket cost would be only somewhere around $20,000.

So, after all these insurance calls, I figured I’d end up paying, out of my own pocket, co-payments totaling between $20,000 and $38,000 for my Acthar gel. Yes, that’s a lot for five thimbles of medicine, but it wouldn’t bankrupt me. Quite.

At that point, I went back to Mallinckrodt, which had told me there were nonprofit organizations that might help me with my Acthar co-payments, whatever they came out to be. Indeed, the company connected me with a nonprofit called The Assistance Fund that helps not-rich people pay for their drugs. When I told The Assistance Fund that I needed Acthar to deal with my “idiopathic membranous glomerular nephritis” — the full name of my disease — they told me they couldn’t help me, because Acthar is “off label” for that disease.

“Off label” is a frightening phrase for those of us taking drugs for a relatively uncommon disease; it means the drug has not yet been approved for that particular disease. When I then explained to The Assistance Fund folks that my disease also led to my experiencing “nephrotic syndrome,” they perked right up: “Oh, that’s okay then!” they said. “We cover that!” What’s in a name. . . .

So, between Medicare, Medicare Part D, and The Assistance Fund, other people are covering almost the full cost of my medicine. I guess this makes me a medical mooch. At the moment, when I get a vial of Acthar gel, I send just $10 to the pharmacy that delivers it to me. My costs are being covered by three groups of people: 1) You — the American taxpayer who pays into Medicare; 2) healthy people who pay their insurance premiums and thus allow insurance companies to cover people when they get sick, and 3) the donors to The Assistance Fund. As I said, you’re paying at least $190,000 (maybe, ultimately, $380,000 if I need more treatments) to help me keep my kidneys.

Like a lot of the long-term sick, I have bad dreams about going to my mailbox tomorrow and finding a letter from Medicare or my insurance company that says, “Oops, sorry! You’re not really covered!” and I will be hit with a bill for hundreds of thousands of dollars that will send me to the poorhouse.

All of this in order for Mallinckrodt to make a billion dollars per year from a drug the company didn’t invent or even do the original medical research on.

As if dealing with the price of Acthar gel and navigating a Byzantine insurance system aren’t enough, I have come across one more circumstance I find a bit unsettling: There are big-money investors on Wall Street who hope I die.

If you Google “Acthar gel,” you are directed to a number of websites. Some, sponsored by Mallinckrodt, tell you how wonderful the drug is. Some, like The New York Times or Washington Post sites, run excellent articles about the history and cost of Acthar gel. Some are online medical journal articles — a few by my own doctor — that detail the research being done on the drug.

And then there are a couple of sites that tell you how dangerous Acthar gel is and how evil Mallinckrodt is. These sites tell you how many people get sicker or die while taking Acthar. They tell you that the government is going to crack down on Mallinckrodt and shrink its profits or put it out of business. It took just a little digging to discover that these sites were created by Wall Street investors who want Mallinckrodt to fail and, by extension, want me to die.

These investors are known as “short sellers.” Simply put, they make money when a stock goes down. There is a notorious Wall Street short seller named Andrew Left who is reported to have a giant multimillion-dollar short-position stake in Mallinckrodt. Andrew Left wants Mallinckrodt’s stock to tank. As I imagine it, that means he wants me to die. If I do, he’ll make money. Trace back the websites focusing on Mallinckrodt’s failures and villainy and you usually come to Andrew Left.

So Mallincrodt makes money if my kidneys recover, and Andrew Left makes money if my kidneys fail. Nice to know that, whatever happens to me, there’s a profit in it for somebody. But not for you — the American taxpayer — or for me. No one is going to refill our wallets.

I don’t think there’s a need here to go into a long policy screed about obscenely high prices for drugs like Acthar gel. On the simplest level, the principle is this: the “free market” has never worked when a company is allowed a monopoly on a necessary product, whether that product is steel, oil, or Acthar. That’s why we have laws forbidding monopolies on oil and steel and other necessary products. I can tell you this: If your child has seizures, your spouse has multiple sclerosis, or your kidneys might otherwise expire in two years, Acthar gel — the $38,000-per-thimble drug — is, if nothing bloody else, necessary.

Meanwhile, Big Pharma continues to run a protection racket, and we pay whatever they ask.

I’m lucky. I’m getting the medicine I need, and I’m not going broke. Now I want to thank all of you for picking up the tab.

Ed Weathers was an editor at Memphis magazine from 1977 to 1991. He later worked as an editor for the New York Times Magazine Group and as a writing instructor at Virginia Tech. He is now retired and lives in Blacksburg, Virginia.